Spain Europe
BIOLOGICS in Europe
Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.
About the plant
Cultiply is a CDMO with extensive experience in the development of microbial strains, the production of recombinant proteins, scale-up services and production with bioreactors of up to 1,000L capacity.
Certifications
- ISO
Activity
- Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Vaccines, BIOLOGICS manufacturing
Features
- Uses: Investigational, Preclinical
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- DEA: Schedule V (lowest potential for abuse)
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities
Batch Size / Reactor
- Small, Medium, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L
Services
- Development services, Manufacturing services, R&D, Process development, Process optimization, Process validation, Downstream, Cell line development, Cell banking, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Batch records
